Empaglo 25 mg (Empagliflozin)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and as an add-on therapy with insulin and other glucose-lowering agents. If this medication is well tolerated at 10 mg and additional blood sugar control is needed, the dose may be increased to 25 mg once daily. This medication can be administered regardless of meals. The tablets should be swallowed whole. If a dose is missed, it should be taken as soon as remembered.

This medication should not be used by individuals with an allergic reaction to the active ingredient or any excipients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with severely reduced kidney function, specifically those with a glomerular filtration rate of less than 30 mL/min/1.73m2, those with end-stage renal disease, or those undergoing dialysis should not use this medication. As this medication contains lactose, it should not be administered to patients with lactose intolerance, galactose intolerance, or genetic lactase deficiency. Caution should be exercised in using this medication in patients with decreased kidney function, and it is particularly advised not to initiate treatment in those with a glomerular filtration rate of less than 60 mL/min/1.73m2, and to discontinue treatment if it falls below 45 mL/min/1.73m2. In cases of severe heart failure, use of this medication is not recommended and care should be taken. When used in conjunction with insulin or sulfonylureas, there may be a risk of hypoglycemia, necessitating dosage adjustments. This medication can cause various adverse reactions, such as hypoglycemia, genital infections, urinary tract infections, increased urination, fluid loss, and elevated serum creatinine levels, so symptoms should be closely monitored. In particular, serious metabolic acidosis known as ketoacidosis may occur, and if symptoms (nausea, vomiting, abdominal pain, difficulty breathing, etc.) arise, immediate treatment should be sought. Elderly patients or those at risk of fluid loss should be vigilant for dehydration and hypotension, and regular monitoring of fluid status is important. This medication may increase the risk of serious infections such as urosepsis, pyelonephritis, and necrotizing fasciitis, so if signs of infection occur, immediate consultation with healthcare professionals is necessary. Use of this medication is not recommended during pregnancy, and it should be discontinued if pregnancy is confirmed. When breastfeeding, it is also safest to discontinue breastfeeding as this medication may be excreted in breast milk. Safety and efficacy in children under 18 years have not been established, and it should not be used in this population. In cases of overdose, clinical status should be closely monitored, and appropriate treatment should be administered. This medication should be stored out of reach of children and should not be transferred to other containers for safety. Caution is needed when driving or operating machinery due to the risk of hypoglycemia. Diabetic patients should pay attention to routine foot care and be cautious about the risk of limb amputation.

Serious side effects

• Hives
• angioedema
• ketoacidosis
• rash
• urinary tract infections
• urosepsis and pyelonephritis
• necrotizing fasciitis

Mild side effects

• Hypoglycemia
• vulvovaginal candidiasis
• balanitis and other genital infections
• increased urination
• dysuria
• interstitial nephritis
• thirst
• increased serum lipids
• elevated blood creatinine
• decreased glomerular filtration rate

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius to ensure the drug's efficacy remains safely intact for a long time.

Appearance

Pale yellow oval film-coated tablet

Package unit

30 tablets/PTP (10 tablets/PTP × 3), 10 tablets/PTP (10 tablets/PTP × 1)